CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)

K992358 · Biopro (M) Sdn Bhd · LYY · Sep 10, 1999 · General Hospital

Device Facts

• Record ID: K992358
• Device Name: CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
• Applicant: Biopro (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free 911 Latex Examination gloves is disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable latex examination gloves; worn on examiner's hand or finger; intended to provide barrier protection against contamination between patient and examiner; used in clinical or medical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Color: Blue. Powder-free. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Mr. Jim Lale BioPro (M) Sdn. Bhd. Lot 14, PT. 4204 Lingkarn Sultan Hishamuddin North Port Industrial Estate 42000 Port Klanq Selangor Darul Ehsan Malaysia

K992358 Re : Correct Touch Power Free 911 Latex Trade Name: Examination Gloves (Blue) Requlatory Class: I Product Code: LYY Dated: July 12, 1999 Received: July 14, 1999

Dear Mr. Lale:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 — Mr. Lale

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 3.0 Indications for Use Statement:

| Applicant: | Biopro (M) Sdn Bhd |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K992358 |
| Device Name: | Powder Free Latex Examination Gloves (colored) BLUE |
| Indications For Use: | The Powder Free 911 Latex Examination gloves is disposable device intended for medical purposes worn on the examiner's hand or finger to prevent |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Olin S. Lin

(Division Sign-Off)

contamination between patient and examiner.

Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992358

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use 1-2-96) (Optional Format

Attachment to Question 3